Axsome Therapeutics AXSM Stock News

Axsome Therapeutics Inc (NASDAQ: AXSM) is flying in the market this morning, trading on gains of more than 60% early on. The gains come after the company positive data from a Phase 3 study. Here’s what’s going on:

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AXSM Stock Heads Up On Positive Data

In a press release issued early this morning, Axsome Therapeutics announced positive data surrounding AXS-05. The treatment is currently being studied as an option for major depressive disorder.

In the release, the company said that the the drug proved to rapidly and significantly improve symptoms of depression, meeting the primary endpoint of the Phase 3 clinical trial.

In the release, AXSM explained that the study was a randomized, double-blind, placebo-controlled, multi-center, US trial. 367 patients with confirmed moderate to severe MDD were randomized in the trial to be treated with either AXS-05 or placebo once daily for the first three days and twice daily thereafter for a total treatment period of 6 weeks.

The company explained that the trial met its primary endpoint by demonstrating a highly statistically significant reduction in MADRS total score compared to placebo at 6 weeks. Mean reductions from basline of 16.6 points were achieved in the treatment arm with mean reductions in the placebo arm coming in at just 11.9 points.

In the release, AXSM said that simptoms were seen to improve in just one week, with further improvements at every time point thereafter.

AXSM also said that rates of remission were statistically significantly greater for AXS-05 when compared to placebo at week 2 and every time point htereafter.

Importantly, the drug not only proved to be effective, but also had a favorable safety and tolerability profile. In a statement, Professor Maurizio Fava, MD, Psychiatrist-in-Chief at Massachusetts General Hospital, had the following to offer with regard to the results released by AXSM this morning:

AXS-05 demonstrated a rapid and very clinically meaningful improvement in depressive symptoms, observed after only one week, in this large and well-controlled Phase 3 trial in major depressive disorder. Given the known challenges of conducting trials in psychiatry, it is very encouraging to see replication of Phase 2 findings in such a robust way.

Clinical depression is a potentially life-threatening condition. Currently marketed antidepressants fail to provide adequate treatment response in almost two thirds of treated patients, and may take up to six to eight weeks to provide clinically meaningful response. These data suggest that AXS-05, as an oral NMDA receptor antagonist with multimodal activity, may represent a novel treatment for major depressive disorder.

This News Is Substantial!

All in all, the news released today was huge for Axsome Therapeutics. The positive data suggests that, should regulatory agencies see the data in the same way, the drug will soon find its way to market. Moreover, with results like these, it may be the most effective treatment on the market, making the drug a blockbuster.

At the moment, it is estimated that the Major Depressive Disorder market will grow to be worth $5.8 billion by the year 2025. Should AXSM truly have the best option on the market, it could be in on a big cash cow ahead. All in all, there’s very good reason for the excitement.

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